High Court stays ban on Pfizer’s Corex syrup sale
2 min read 14 Mar 2016, 05:32 PM ISTCourt observes that the government action to ban the drug appeared to have been arbitrary and rushed
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New Delhi: In a major relief to US pharmaceutical Pfizer Inc.’s India unit, the Delhi high court on Monday granted a stay on a government ban on its cough syrup Corex.
The government banned 344 drug combinations last week after a panel of experts found they posed a health risk.
Earlier in the day, in a statement to the BSE, Pfizer India said that the prohibition of the drug would likely adversely impact the company’s revenue and profitability. Corex recorded sales of ₹ 176 crore for the first nine months of the financial year ended on 31 December 2015.
Pharmaceutical firm Abbott, which sells the syrup under the Phensedyl brand name, had also approached the court and its plea will be taken up for hearing on Tuesday. Phensedyl sales are estimated to account for around 3% of Abbott’s $1 billion India revenue.
“The notification was issued by the government without any inquiry or show-cause notice to them, with complete disregard to the fact that we have been marketing the drugs in questions since the last 25 years," senior advocate Kapil Sibal appearing for Pfizer told justice Rajiv Sahai Endlaw, who was hearing the matter.
The Delhi high court observed that the government action appeared to have been arbitrary and rushed. It also noted that no inquiry or show-cause notice had been issued to Pfizer before the notification was passed.
Endlaw sought an affidavit from the centre with the findings of the expert committee which formed the basis of the ban. The government clarified that such drugs were “likely to involve risk to humans" when safer alternatives are available in the market and were devoid of “therapeutic justification".
“The major segments impacted are respiratory, pain and analgesics and anti-diabetic markets. The companies which are impacted in terms of value are led by Abbott Healthcare followed by Macleods Pharma and Pfizer India. The brands majorly impacted are led by Corex, Phensedyl and Panderm Plus," said an industry lobby official, who did not want to be named.
Shares of Pfizer fell 8.67% on Monday, while Abbott India’s shares were up by 0.32% on the BSE.
“We have received an interim injunction suspending the operation of the said notification banning the manufacture for sale, sale and distribution of fixed dose combination of Chlopheniramine Maleate + Codeine Syrup till the next date of hearing. We are awaiting the order from the Delhi high court. Corex has a well-established efficacy and safety profile in India for more than 30 years and has both central and state licenses and approvals. Pfizer makes every effort to maintain the highest standards of regulatory and quality compliance in the manufacture and distribution of Corex," a Pfizer spokesperson said in statement.
Corex is a combination of chlopheniramine maleate and codeine, often prescribed by doctors to patients suffering from cough and cold. Around half dozen codeine-related fixed combinations were part of the government’s banned drugs list.
Codeine, a sleep-inducing and analgesic drug, is an opiate derived from morphine, and sometimes lead to abuse.
“The centre is satisfied that the use of the drug fixed dose combination of chlopheniramine maleate plus codeine syrup is likely to involve risk to human beings, whereas safer alternatives are available," the government said in its notification.
The court will hear the matter next on 21 March.
